RECRUITING

Tissue Repair Gel in Venous Leg Ulcers in AU/US

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs). It will also provide additional information about the safety of drug TR987 0.1% gel.

Official Title

A Phase 3 Randomized, Parallel Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, and Safety of TR987® 0.1% Gel Versus Standard of Care in the Treatment of Chronic Venous Insufficiency Leg Ulcers (VLU)

Quick Facts

Study Start:2024-11
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06707103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults 18 years and older
  2. * Venous insufficiency has been clinically diagnosed clinically and medically confirmed.
  3. * Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control.
  4. * The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization.
  5. * Target ulcer age must be ≥ 4 weeks at Screening.
  6. * Participants must have adequate arterial flow as confirmed by ABI/TBI, TB, SPP, or TCPo2.
  7. * Body mass index (BMI) ≤ 42 kg/m2.
  8. * HbA1C ≤12%.
  1. * Target ulcer has been treated with prohibited medications or therapies.
  2. * History of radiation at the target ulcer site.
  3. * Target ulcer decreases in area by 30% or more during screening period.
  4. * History of osteomyelitis at the target ulcer within 6 months of screening.
  5. * History of cancer in the preceding 5 years (except as noted in the protocol).
  6. * Participants considered nutritionally deficient.

Contacts and Locations

Study Contact

Anhthu Nguyen Vice President, Global Clinical Operations
CONTACT
(+61) 280 034 554
anhthu.nguyen@trtherapeutics.com

Study Locations (Sites)

Clincial Research Site 92
Jacksonville, Florida, 32256
United States
Clincial Research Site 77
Clinton Twp, Michigan, 48038
United States
Clincial Research Site 82
Lake Success, New York, 11042
United States
Clinical Research Site 76
Fort Worth, Texas, 76104
United States

Collaborators and Investigators

Sponsor: TR Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11
Study Completion Date2027-02

Study Record Updates

Study Start Date2024-11
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • Tissue Repair
  • Glucoprime
  • TR Therapeutics
  • Debridement
  • VLU

Additional Relevant MeSH Terms

  • Venous Leg Ulcer
  • Venous Ulcer
  • Venous Stasis Ulcer
  • Venous Stasis
  • Wound Heal
  • Wound
  • Venous Insufficiency of Leg
  • Non-healing Wound